Generic Name: sofosbuvir velpatasvir voxilaprevir
Brand Name: Vosevi
Manufacturer: Gilead Sciences Canada, Inc.
Indications: Hepatitis C, chronic
Submission Type: New Combination
Project Status: Complete
Biosimilar: No
Date Recommendation Issued: January 23, 2018
Recommendation Type: Reimburse with clinical criteria and/or conditions
Fee Schedule: Schedule A
Key Milestones2 | |
---|---|
Call for patient input posted | July 07, 2017 |
Patient group input closed | August 28, 2017 |
Clarification: Patient input submission received | |
Patient input summary sent for review to patient input groups | August 30, 2017 |
Patient group comments on input summary closed | September 07, 2017 |
Clarification: - Patient input summary feedback received | |
Submission received | July 28, 2017 |
Submission accepted for review | August 14, 2017 |
Review initiated | August 15, 2017 |
Draft CDR review report(s) sent to applicant | October 30, 2017 |
Comments from applicant on draft CDR review report(s) received | November 08, 2017 |
Redaction requests from applicant on draft CDR review report(s) received | November 15, 2017 |
CDR review team's comments on draft CDR review report(s) sent to applicant | December 01, 2017 |
Canadian Drug Expert Committee (CDEC) meeting | December 13, 2017 |
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans | January 02, 2018 |
Embargo period ended and validation of redacted CDR review report(s) received | January 16, 2018 |
CDEC Final Recommendation issued to applicant and drug plans | January 23, 2018 |
CDEC Final Recommendation posted | January 25, 2018 |
Final CDR review report(s) and patient input posted | February 07, 2018 |